Clinical Evaluation

Clinical Evaluation

To be beneficial to patients, medical devices must be effective, with adequate clinical effect levels. At the same time, they should expose patients to the least possible risk. In addition to technical safety and performance, our clinical evaluation of medical devices must therefore be able to demonstrate clinical efficacy and effect size, burden and risks, and the reasonableness of the benefit / risk ratio through a clinical evaluation of your products. Clinical evaluation of a patient may also be required for clinical evaluation.

According to the new EU MDR, this proof of the clinical effectiveness of a medical device and of patient protection is generally provided by a clinical evaluator, namely by means of a specialist clinical evaluation of medical devices. We use proprietary, intelligent clinical evaluation tools . More often than before, a clinical trial according to EN ISO 14155 is required. At the same time, the manufacturer must submit a clinical development plan. A waiver of a clinical evaluation is usually intended only for non-critical products.

Tightened clinical requirements of the new Medical Devices Regulation of 2017 in six areas

The current clinical procedures for CE approval according to the German MPG and the European guidelines MDD / AIMDD / IVD expire in 2020. Old certificates will end no later than 2024. With regard to the clinical evaluation, the main differences between EU Directive 93/42 and EU Regulation 2017/745 can be found in the following areas:

Clinical development plan

Clinical development plan

For the clinical evaluation of medical devices, it is new, according to the EU MDR, that manufacturers may have a clinical development plan including ...

Clinical evaluation procedure

Clinical evaluation procedure

The new EU regulations have the requirements for the burden of proof of safety and efficacy by means of clinical evaluation and if necessary. ...

Revaluation of old certificates

Revaluation of old certificates

Clinical reassessment of approved medical devices with existing certificates between 2020 and 2024 The new EU MDR will apply from 26 May 2020. Products already approved for the market must be submitted no later than 5 ...

Clinical examination

Clinical examination

If sufficient clinical evidence is not available to demonstrate the required clinical safety and performance of a product, clinical trials must be carried out ...

Software review

Software review

Special features of the clinical evaluation of stand-alone software. According to Classification Rule 11 EU-MDR, individual software (eg identifiable by the restriction to (possibly graphic GUI) is used).

Elimination of clinical evaluation ?

Elimination of clinical evaluation ?

A waiver of clinical data in a clinical evaluation is only intended for absolutely non-critical products (MDR, Annex X, section 1.1d). The exception is with proof of the ...

Gap analysis

Gap analysis

Existing gaps in clinical documentation and assessment must be uncovered and closed. This may require clinical trials or post-marketing surveillance. ...

Clinical documentation

Clinical documentation

Documentation for Clinical Conformity Assessment In addition to the medical quality of the clinical assessment, its documentation and traceability must also be documented in the context of complex reports and ...

Clinical PMS

Clinical PMS

Continuous post-marketing clinical monitoring. After the market launch of the medical device, according to the new MDR (Annex XI ...

Recertification

Recertification

The CE marking is limited in time After the initial certification, the notified body carries out annual repeat audits ....

Tools

Tools

Our seven implementation modules as intelligent tools for tailor-made solutions Our proprietary implementation modules cover all the typical questions of manufacturers from the first ...

Tübingen / Stuttgart Office

Bismarckstr. 66
72072 Tübingen

Phone: (+49) 700-02 98 80 13
Email.: office@hpzenner.de

Munich Office

Oettingenstr. 8a
80538 Munich

Phone: (+49) 89 255-46434
E-mail: office@hpzenner.de